A Long-term Safety Study With Tapentadol ER and Oxycodone CR in Patients With Moderate to Severe Pain Due to Chronic, Painful Diabetic Peripheral Neuropathy (DPN)

NCT01063868 | Terminated Phase 3 Results

• 3 other identifiers: CR016978R331333PAI3028KF57
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 23

Brief Summary

The purpose of this study is to evaluate the safety profile of orally administered tapentadol ER dosages of 100 to 250 mg twice daily in patients with chronic, painful diabetic peripheral neuropathy (DPN) over long-term exposure of up to 1 year.

Conditions

Diabetic Neuropathy, Painful; Diabetic Polyneuropathy

Keywords

Diabetic neuropathy; Painful; Polyneuropathy; Peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Treatment-emergent Adverse Events (TEAE)

  The number of participants who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication.

  Entire Study

Study Arms (2)

001

EXPERIMENTAL

Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks

Drug: Tapentadol extended release (ER)

002

ACTIVE COMPARATOR

Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks

Drug: Oxycodone controlled release (CR)

Interventions

Tapentadol extended release (ER) DRUG

100, 150, 200, 250 mg twice daily for 52 weeks

001

Oxycodone controlled release (CR) DRUG

20, 30, 40, 50 mg twice daily for 52 weeks

002

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Man or woman aged 18 years or older
• Patients with Type 1 or 2 diabetes mellitus must have a documented clinical diagnosis of painful diabetic peripheral neuropathy with symptoms and signs for at least 6 months, and pain present at the time of screening
• Diagnosis must include pain plus reduction or absence of pin sensibility and/or vibration sensibility on Total Neuropathy Score - Nurse (TNSn) examination in lower and/or upper extremities at screening
• The investigator considers the patient's blood glucose to be controlled by diet, or hypoglycemics, or insulin for at least 3 months prior to enrolling in the study (this control should be documented by figures of glycated hemoglobin (HbA1c) no greater than 11% at screening)
• Patients have been taking analgesic medications for the condition for at least 3 months prior to screening (patients taking opioid analgesics must be dissatisfied with current treatment, and patients taking non-opioid analgesics must be dissatisfied with current analgesia)
• Patients currently requiring opioid treatment must be taking daily doses of an opioid-based analgesic equivalent to \<=160mg of oral morphine
• Patients with baseline score for average pain intensity in the previous 24 hours of =\>4 on the 11-point numerical rating scale (NRS) at the beginning of the titration period

You may not qualify if:

• Significant pulmonary, gastrointestinal, endocrine, metabolic (except diabetes mellitus), neurological, psychiatric disorders (resulting in disorientation, memory impairment or inability to report accurately as in schizophrenia, Alzheimer's disease)
• History of moderate to severe hepatic impairment
• Severely impaired renal function
• Clinically significant laboratory abnormalities
• Clinically significant cardiac disease
• History of seizure disorder or epilepsy
• History of any other clinically significant disease that in the investigator's opinion may affect efficacy or safety assessments or may compromise patient safety during study participation.

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Grünenthal GmbH: collaborator

Study Sites (23)

Unknown Facility

Mesa, Arizona, United States

Location

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Tucson, Arizona, United States

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Fruitland Park, Florida, United States

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New Port Richey, Florida, United States

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Oviedo, Florida, United States

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Tampa, Florida, United States

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Libertyville, Illinois, United States

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Franklin, Indiana, United States

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Paducah, Kentucky, United States

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Wellesley Hills, Massachusetts, United States

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Albuquerque, New Mexico, United States

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New York, New York, United States

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Greenville, North Carolina, United States

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Hickory, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Kettering, Ohio, United States

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Tulsa, Oklahoma, United States

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Greer, South Carolina, United States

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Dallas, Texas, United States

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Odessa, Texas, United States

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San Antonio, Texas, United States

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Unknown Facility

Virginia Beach, Virginia, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Pain; Polyneuropathies; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Early termination, due to sponsor's discretion, lead to only 47 patients out of the 800 planned (5.9%) being available for analysis. The data should be interpreted with caution.

Results Point of Contact

• Title: Senior Director, Clinical Leader
• Organization: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

609-730-4537

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 5, 2010
• Study Start: January 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: June 1, 2010
• Last Updated: March 4, 2014
• Results First Posted: May 10, 2011

Record last verified: 2013-01

Locations

US (23)